Senior Vice President, Regulatory Affairs
Description
Premier Consulting, a division of Premier Research, is seeking a Senior Vice President, Regulatory Affairs. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Develops and implements strategic plans and objectives for organization growth in alignment with corporate strategy in delivery of high-quality regulatory services to clients and provide advice in support of clinical development planning.
- Provides leadership to teams in the preparation of regulatory strategies, review of clinical development plans, and health authority interactions for clients
- Key responsibility for building cross-functional alliances both within Premier Consulting as well with Premier Research. This includes advising internal development functions such as Clinical, Medical, Nonclinical and CMC regarding regulatory impact of development decisions
- Manages the organizational structure, staffing, resourcing, and supervision of the Global Regulatory Affairs function including line management responsibilities for multiple Regulatory Affairs sites and/or regions
- Supports Business Development efforts for opportunities including proposals, budgets, pitching calls and bid defense meetings
What we’re searching for:
- Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred
- BA/BS and 16-18 years of related experience or MA and 14-16 years of related experience or PhD and 12-14 years of related experience in the pharmaceutical, CRO or biotechnology industry, involving the conduct of clinical trials.
- Minimum of 10-15 years’ experience of managing people or processes in the regulatory affairs department.
- Experience in the preparation of regulatory submissions in the US and Europe is required
- Experience with supervisory and financial management responsibility of a regulatory affairs department or component thereof (prior experience and responsibility for financial management of a regulatory department of a CRO, pharmaceutical or consulting firm)
- Experience working in multidisciplinary project teams
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.
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